FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION NASAL CPAP SYSTEM
K Number: K020730
·
Decision May 22, 2002
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
35
Review Days
77
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Basic Information
- Device Name
- ORION NASAL CPAP SYSTEM
- K Number
- K020730
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bird Products Corp.
- Date Received
- March 6, 2002
- Decision Date
- May 22, 2002
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by Bird Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K032451 | BIRD TBIRD VELA VENTILATOR | Mar 17, 2004 | Substantially Equivalent |
| K022674 | BIRD AVEA VENTILATOR | Nov 6, 2002 | Substantially Equivalent |
| K013642 | AVEA | May 22, 2002 | Substantially Equivalent |
| K020746 | BIRD TBIRD VELA VENTILATOR | Apr 22, 2002 | Substantially Equivalent |
| K003770 | BIRD TBIRD LEGACY VENTILATOR | Dec 15, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K990856 | HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 | Jan 11, 2000 | Substantially Equivalent |
| K993449 | BIRD V.I.P. GOLD/STERLING | Dec 20, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K982580 | BIRD MONITOR INTERFACE | Oct 22, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K981971 | TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 | Aug 24, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K973646 | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER | May 7, 1998 | Substantially Equivalent |